Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.

Part of paid clinical trials in Tampa, Florida.

Sponsor
Epitel, Inc.
Study ID
NCT06027749
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Epitel's™ Remote EEG Monitoring System's (REMI™) — DEVICE
    Ambulatory electroencephalography (EEG) monitoring

Study Details

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Key Dates

Start date
Oct 13, 2023
Status verified
Aug 2024
Primary completion
Mar 30, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Primary Outcome Measure

Ictal Events Identified in fourteen (14) days. [ Time Frame: Fourteen (14) days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33606
Marina Azevedo, BSc
[email protected]
813-250-2323
Ana Omura, BSc
[email protected]
813-259-8524
Salim Benbadis, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29407-

Find similar trials in Tampa, FL

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of South Florida· Tampa, FLMedical University of South Carolina· Charleston, SC

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